OncoMatch/Clinical Trials/NCT02062489
Evaluation of Tamoxifen's Efficacy for ER/PR Negative,ER-beta Positive Operable Breast Cancer Patients
Is NCT02062489 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Tamoxifen for breast cancer.
Treatment: Tamoxifen — The current study is a multicentre, randomized,double-blind, prospective clinical trial stratified patients by the HER2 status of their cancer (negative or positive) which is sponsored by the researchers. The trial is designed to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients. 688 female ER(ER-α)/PR negative, ER-β(wild type ER-β1) positive operable breast cancer patients who had undergone neoadjuvant chemotherapy or directly modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive tamoxifen (20 mg per day) or placebo (2# per day) within 6 weeks after postoperative chemotherapy and/or radiation therapy if needed (according to 2013 NCCN breast cancer guideline). If the breast tumor's HER2 is positive, the patient can receive targeted therapy (Herceptin) combined with tamoxifen or placebo. The follow-up time will be eight years. The aim of this trial is to evaluate the effectiveness of tamoxifen as adjuvant therapy for ER(ER-α)/PR negative, ER-β positive operable breast cancer patients by comparing the DFS and OS between tamoxifen group and placebo group and to determine whether the percentage of positive ER-β expression is associated with the response to the hormone therapy in breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative expression (<1% by IHC) (<1% by IHC)
The breast tumor's positive ER/PR rate is <1% by IHC
Required: PR (PGR) negative expression (<1% by IHC) (<1% by IHC)
The breast tumor's positive ER/PR rate is <1% by IHC
Required: ESR2 positive expression (≥10% by IHC) (≥10% by IHC)
positive ER-beta1 rate is ≥10% by IHC
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — neoadjuvant
The patients underwent neoadjuvant chemotherapy plus surgery
Must have received: surgery — definitive
directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection)
Must have received: chemotherapy — adjuvant
The patients underwent chemotherapy ... after surgery according to the 2013 NCCN guideline
Must have received: radiation therapy — adjuvant
The patients underwent ... radiation therapy ... after surgery according to the 2013 NCCN guideline
Must have received: HER2-targeted therapy (herceptin) — adjuvant
The patients underwent ... targeted therapy(herceptin) after surgery according to the 2013 NCCN guideline
Cannot have received: hormonal therapy
The patients have no history of neoadjuvant hormone therapy
Lab requirements
Blood counts
hb≥90g/l; wbc≥4.0×109/l; plt≥100×109/l; neutrophils≥1.5×109/l
Kidney function
creatinine ≤ 1.25 times of normal upper limit
Liver function
alt and ast ≤ triple of normal upper limit; tbil ≤ 1.5 times of normal upper limit
Cardiac function
normal cardiac functions by echocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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